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Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC) (EVIEPEB)

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ClinicalTrials.gov Identifier: NCT00960271
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Procedure: EBUS

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Study Type : Observational
Actual Enrollment : 363 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging
Study Start Date : September 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
NON SMALL CELL LUNG CANCER
Non small cell lung cancer, with clinical N2 disease, otherwise operable.
Procedure: EBUS
a minimally invasive technique of mediastinal lymph node staging using an integrated videoendoscopic device equipped with ultrasound for the localization and transbronchial sampling of lymph nodes in real time
Other Name: NSCLC




Primary Outcome Measures :
  1. number of mediastinoscopy avoided [ Time Frame: 24h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include non small cell lung cancer patients, stage III A (before PET Scan), with resectable tumors.
Criteria

Inclusion Criteria:

  • adult patients over 18
  • non small cell lung cancer histologically or cytologically proved
  • Clinical Stage IIIA
  • anatomically and functionally resectable

Exclusion Criteria:

  • uncorrected bleeding disorders
  • absence of lymphadenopathy superior to 1cm in small axis at CT scan
  • contraindication to bronchoscopy
  • extrathoracic or intrathoracic metastasis
  • respiratory function tests not compatible with curative resection of lung cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960271


Locations
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France
Rouen University Hospital
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Rouen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00960271     History of Changes
Other Study ID Numbers: 2007/138/HP
EVIEPEB
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013
Keywords provided by University Hospital, Rouen:
Non-small cell lung cancer
mediastinal lymph node
resectable
EBUS
stage IIIA
significant mediastinal lymph node at thoracic CT Scan
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms